Humidifier reservoir

ABSTRACT

A water reservoir for an apparatus for humidifying a flow of breathable gas includes a reservoir base including a cavity structured to hold a volume of liquid and a conductive portion provided to the base. The conductive portion is adapted to thermally engage with a heater plate to allow thermal transfer of heat from the heater plate to the volume of liquid. The conductive portion includes a thin film comprising a non-metallic material, and the thin film includes a wall thickness less than about 1 mm.

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in Patent Office patent files orrecords, but otherwise reserves all copyright rights whatsoever.

1 CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/346,329, filed Apr. 30, 2019, which is the U.S. national phase ofInternational Application No. PCT/AU2017/051276 filed Nov. 21, 2017which designated the U.S. and claims the benefit of AustralianProvisional Application No. 2016904769, filed Nov. 22, 2016, the entirecontents of each of which are hereby incorporated by reference.

2 BACKGROUND OF THE TECHNOLOGY 2.1 Field of the Technology

The present technology relates to one or more of the detection,diagnosis, treatment, prevention and amelioration of respiratory-relateddisorders. The present technology also relates to medical devices orapparatus, and their use.

2.2 Description of the Related Art 2.2.1 Human Respiratory System andits Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

The airways include a series of branching tubes, which become narrower,shorter and more numerous as they penetrate deeper into the lung. Theprime function of the lung is gas exchange, allowing oxygen to move fromthe inhaled air into the venous blood and carbon dioxide to move in theopposite direction. The trachea divides into right and left mainbronchi, which further divide eventually into terminal bronchioles. Thebronchi make up the conducting airways, and do not take part in gasexchange. Further divisions of the airways lead to the respiratorybronchioles, and eventually to the alveoli. The alveolated region of thelung is where the gas exchange takes place, and is referred to as therespiratory zone. See “Respiratory Physiology”, by John B. West,Lippincott Williams & Wilkins, 9th edition published 2012.

A range of respiratory disorders exist. Certain disorders may becharacterised by particular events, e.g. apneas, hypopneas, andhyperpneas.

Examples of respiratory disorders include Obstructive Sleep Apnea (OSA),Cheyne-Stokes Respiration (CSR), respiratory insufficiency, ObesityHyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease(COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing(SDB), is characterised by events including occlusion or obstruction ofthe upper air passage during sleep. It results from a combination of anabnormally small upper airway and the normal loss of muscle tone in theregion of the tongue, soft palate and posterior oropharyngeal wallduring sleep. The condition causes the affected patient to stopbreathing for periods typically of 30 to 120 seconds in duration,sometimes 200 to 300 times per night. It often causes excessive daytimesomnolence, and it may cause cardiovascular disease and brain damage.The syndrome is a common disorder, particularly in middle agedoverweight males, although a person affected may have no awareness ofthe problem. See U.S. Pat. No. 4,944,310 (Sullivan).

Cheyne-Stokes Respiration (CSR) is another form of sleep disorderedbreathing. CSR is a disorder of a patient's respiratory controller inwhich there are rhythmic alternating periods of waxing and waningventilation known as CSR cycles. CSR is characterised by repetitivede-oxygenation and re-oxygenation of the arterial blood. It is possiblethat CSR is harmful because of the repetitive hypoxia. In some patientsCSR is associated with repetitive arousal from sleep, which causessevere sleep disruption, increased sympathetic activity, and increasedafterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).

Respiratory failure is an umbrella term for respiratory disorders inwhich the lungs are unable to inspire sufficient oxygen or exhalesufficient CO₂ to meet the patient's needs. Respiratory failure mayencompass some or all of the following disorders.

A patient with respiratory insufficiency (a form of respiratory failure)may experience abnormal shortness of breath on exercise.

Obesity Hyperventilation Syndrome (OHS) is defined as the combination ofsevere obesity and awake chronic hypercapnia, in the absence of otherknown causes for hypoventilation. Symptoms include dyspnea, morningheadache and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a groupof lower airway diseases that have certain characteristics in common.These include increased resistance to air movement, extended expiratoryphase of respiration, and loss of the normal elasticity of the lung.Examples of COPD are emphysema and chronic bronchitis. COPD is caused bychronic tobacco smoking (primary risk factor), occupational exposures,air pollution and genetic factors. Symptoms include: dyspnea onexertion, chronic cough and sputum production.

Neuromuscular Disease (NMD) is a broad term that encompasses manydiseases and ailments that impair the functioning of the muscles eitherdirectly via intrinsic muscle pathology, or indirectly via nervepathology. Some NMD patients are characterised by progressive muscularimpairment leading to loss of ambulation, being wheelchair-bound,swallowing difficulties, respiratory muscle weakness and, eventually,death from respiratory failure. Neuromuscular disorders can be dividedinto rapidly progressive and slowly progressive: (i) Rapidly progressivedisorders: Characterised by muscle impairment that worsens over monthsand results in death within a few years (e.g. Amyotrophic lateralsclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers);(ii) Variable or slowly progressive disorders: Characterised by muscleimpairment that worsens over years and only mildly reduces lifeexpectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic musculardystrophy). Symptoms of respiratory failure in NMD include: increasinggeneralised weakness, dysphagia, dyspnea on exertion and at rest,fatigue, sleepiness, morning headache, and difficulties withconcentration and mood changes.

Chest wall disorders are a group of thoracic deformities that result ininefficient coupling between the respiratory muscles and the thoraciccage. The disorders are usually characterised by a restrictive defectand share the potential of long term hypercapnic respiratory failure.Scoliosis and/or kyphoscoliosis may cause severe respiratory failure.Symptoms of respiratory failure include: dyspnea on exertion, peripheraloedema, orthopnea, repeated chest infections, morning headaches,fatigue, poor sleep quality and loss of appetite.

A range of therapies have been used to treat or ameliorate suchconditions. Furthermore, otherwise healthy individuals may takeadvantage of such therapies to prevent respiratory disorders fromarising. However, these have a number of shortcomings.

2.2.2 Therapy

Various therapies, such as Continuous Positive Airway Pressure (CPAP)therapy, Non-invasive ventilation (NIV) and Invasive ventilation (IV)have been used to treat one or more of the above respiratory disorders.

Continuous Positive Airway Pressure (CPAP) therapy has been used totreat Obstructive Sleep Apnea (OSA). The mechanism of action is thatcontinuous positive airway pressure acts as a pneumatic splint and mayprevent upper airway occlusion, such as by pushing the soft palate andtongue forward and away from the posterior oropharyngeal wall. Treatmentof OSA by CPAP therapy may be voluntary, and hence patients may electnot to comply with therapy if they find devices used to provide suchtherapy one or more of: uncomfortable, difficult to use, expensive andaesthetically unappealing.

Non-invasive ventilation (NIV) provides ventilatory support to a patientthrough the upper airways to assist the patient breathing and/ormaintain adequate oxygen levels in the body by doing some or all of thework of breathing. The ventilatory support is provided via anon-invasive patient interface. NIV has been used to treat CSR andrespiratory failure, in forms such as OHS, COPD, NMD and Chest Walldisorders. In some forms, the comfort and effectiveness of thesetherapies may be improved.

Invasive ventilation (IV) provides ventilatory support to patients thatare no longer able to effectively breathe themselves and may be providedusing a tracheostomy tube. In some forms, the comfort and effectivenessof these therapies may be improved.

2.2.3 Treatment Systems

These therapies may be provided by a treatment system or device. Suchsystems and devices may also be used to diagnose a condition withouttreating it.

A treatment system may comprise a Respiratory Pressure Therapy Device(RPT device), an air circuit, a humidifier, a patient interface, anddata management.

Another form of treatment system is a mandibular repositioning device.

2.2.3.1 Patient Interface

A patient interface may be used to interface respiratory equipment toits wearer, for example by providing a flow of air to an entrance to theairways. The flow of air may be provided via a mask to the nose and/ormouth, a tube to the mouth or a tracheostomy tube to the trachea of apatient. Depending upon the therapy to be applied, the patient interfacemay form a seal, e.g., with a region of the patient's face, tofacilitate the delivery of gas at a pressure at sufficient variance withambient pressure to effect therapy, e.g., at a positive pressure ofabout 10 cmH₂O relative to ambient pressure. For other forms of therapy,such as the delivery of oxygen, the patient interface may not include aseal sufficient to facilitate delivery to the airways of a supply of gasat a positive pressure of about 10 cmH₂O.

Certain other mask systems may be functionally unsuitable for thepresent field. For example, purely ornamental masks may be unable tomaintain a suitable pressure. Mask systems used for underwater swimmingor diving may be configured to guard against ingress of water from anexternal higher pressure, but not to maintain air internally at a higherpressure than ambient.

Certain masks may be clinically unfavourable for the present technologye.g. if they block airflow via the nose and only allow it via the mouth.

Certain masks may be uncomfortable or impractical for the presenttechnology if they require a patient to insert a portion of a maskstructure in their mouth to create and maintain a seal via their lips.

Certain masks may be impractical for use while sleeping, e.g. forsleeping while lying on one's side in bed with a head on a pillow.

The design of a patient interface presents a number of challenges. Theface has a complex three-dimensional shape. The size and shape of nosesand heads varies considerably between individuals. Since the headincludes bone, cartilage and soft tissue, different regions of the facerespond differently to mechanical forces. The jaw or mandible may moverelative to other bones of the skull. The whole head may move during thecourse of a period of respiratory therapy.

As a consequence of these challenges, some masks suffer from being oneor more of obtrusive, aesthetically undesirable, costly, poorly fitting,difficult to use, and uncomfortable especially when worn for longperiods of time or when a patient is unfamiliar with a system. Wronglysized masks can give rise to reduced compliance, reduced comfort andpoorer patient outcomes. Masks designed solely for aviators, masksdesigned as part of personal protection equipment (e.g. filter masks),SCUBA masks, or for the administration of anaesthetics may be tolerablefor their original application, but nevertheless such masks may beundesirably uncomfortable to be worn for extended periods of time, e.g.,several hours. This discomfort may lead to a reduction in patientcompliance with therapy. This is even more so if the mask is to be wornduring sleep.

CPAP therapy is highly effective to treat certain respiratory disorders,provided patients comply with therapy. If a mask is uncomfortable, ordifficult to use a patient may not comply with therapy. Since it isoften recommended that a patient regularly wash their mask, if a mask isdifficult to clean (e.g., difficult to assemble or disassemble),patients may not clean their mask and this may impact on patientcompliance.

While a mask for other applications (e.g. aviators) may not be suitablefor use in treating sleep disordered breathing, a mask designed for usein treating sleep disordered breathing may be suitable for otherapplications.

For these reasons, patient interfaces for delivery of CPAP during sleepform a distinct field.

2.2.3.1.1 Seal-Forming Structure

Patient interfaces may include a seal-forming structure. Since it is indirect contact with the patient's face, the shape and configuration ofthe seal-forming structure can have a direct impact the effectivenessand comfort of the patient interface.

A patient interface may be partly characterised according to the designintent of where the seal-forming structure is to engage with the face inuse. In one form of patient interface, a seal-forming structure maycomprise a first sub-portion to form a seal around the left naris and asecond sub-portion to form a seal around the right naris. In one form ofpatient interface, a seal-forming structure may comprise a singleelement that surrounds both nares in use. Such single element may bedesigned to for example overlay an upper lip region and a nasal bridgeregion of a face. In one form of patient interface a seal-formingstructure may comprise an element that surrounds a mouth region in use,e.g. by forming a seal on a lower lip region of a face. In one form ofpatient interface, a seal-forming structure may comprise a singleelement that surrounds both nares and a mouth region in use. Thesedifferent types of patient interfaces may be known by a variety of namesby their manufacturer including nasal masks, full-face masks, nasalpillows, nasal puffs and oro-nasal masks.

A seal-forming structure that may be effective in one region of apatient's face may be inappropriate in another region, e.g. because ofthe different shape, structure, variability and sensitivity regions ofthe patient's face. For example, a seal on swimming goggles thatoverlays a patient's forehead may not be appropriate to use on apatient's nose.

Certain seal-forming structures may be designed for mass manufacturesuch that one design fit and be comfortable and effective for a widerange of different face shapes and sizes. To the extent to which thereis a mismatch between the shape of the patient's face, and theseal-forming structure of the mass-manufactured patient interface, oneor both must adapt in order for a seal to form.

One type of seal-forming structure extends around the periphery of thepatient interface, and is intended to seal against the patient's facewhen force is applied to the patient interface with the seal-formingstructure in confronting engagement with the patient's face. Theseal-forming structure may include an air or fluid filled cushion, or amoulded or formed surface of a resilient seal element made of anelastomer such as a rubber. With this type of seal-forming structure, ifthe fit is not adequate, there will be gaps between the seal-formingstructure and the face, and additional force will be required to forcethe patient interface against the face in order to achieve a seal.

Another type of seal-forming structure incorporates a flap seal of thinmaterial positioned about the periphery of the mask so as to provide aself-sealing action against the face of the patient when positivepressure is applied within the mask. Like the previous style of sealforming portion, if the match between the face and the mask is not good,additional force may be required to achieve a seal, or the mask mayleak. Furthermore, if the shape of the seal-forming structure does notmatch that of the patient, it may crease or buckle in use, giving riseto leaks.

Another type of seal-forming structure may comprise a friction-fitelement, e.g. for insertion into a naris, however some patients findthese uncomfortable.

Another form of seal-forming structure may use adhesive to achieve aseal. Some patients may find it inconvenient to constantly apply andremove an adhesive to their face.

A range of patient interface seal-forming structure technologies aredisclosed in the following patent applications, assigned to ResMedLimited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in the Adam Circuit manufactured byPuritan Bennett. Another nasal pillow, or nasal puff is the subject ofU.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-BennettCorporation.

ResMed Limited has manufactured the following products that incorporatenasal pillows: SWIFT™ nasal pillows mask, SWIFT™ II nasal pillows mask,SWIFT™ LT nasal pillows mask, SWIFT™ FX nasal pillows mask and MIRAGELIBERTY™ full-face mask. The following patent applications, assigned toResMed Limited, describe examples of nasal pillows masks: InternationalPatent Application WO2004/073,778 (describing amongst other thingsaspects of the ResMed Limited SWIFT™ nasal pillows), US PatentApplication 2009/0044808 (describing amongst other things aspects of theResMed Limited SWIFT™ LT nasal pillows); International PatentApplications WO 2005/063,328 and WO 2006/130,903 (describing amongstother things aspects of the ResMed Limited MIRAGE LIBERTY™ full-facemask); International Patent Application WO 2009/052,560 (describingamongst other things aspects of the ResMed Limited SWIFT™ FX nasalpillows).

2.2.3.1.2 Positioning and Stabilising

A seal-forming structure of a patient interface used for positive airpressure therapy is subject to the corresponding force of the airpressure to disrupt a seal. Thus a variety of techniques have been usedto position the seal-forming structure, and to maintain it in sealingrelation with the appropriate portion of the face.

One technique is the use of adhesives. See for example US PatentApplication Publication No. US 2010/0000534. However, the use ofadhesives may be uncomfortable for some.

Another technique is the use of one or more straps and/or stabilisingharnesses. Many such harnesses suffer from being one or more ofill-fitting, bulky, uncomfortable and awkward to use.

2.2.3.2 Respiratory Pressure Therapy (RPT) Device

A respiratory pressure therapy (RPT) device may be used to deliver oneor more of a number of therapies described above, such as by generatinga flow of air for delivery to an entrance to the airways. The flow ofair may be pressurised. Examples of RPT devices include a CPAP deviceand a ventilator.

Air pressure generators are known in a range of applications, e.g.industrial-scale ventilation systems. However, air pressure generatorsfor medical applications have particular requirements not fulfilled bymore generalised air pressure generators, such as the reliability, sizeand weight requirements of medical devices. In addition, even devicesdesigned for medical treatment may suffer from shortcomings, pertainingto one or more of: comfort, noise, ease of use, efficacy, size, weight,manufacturability, cost, and reliability.

An example of the special requirements of certain RPT devices isacoustic noise.

Table of noise output levels of prior RPT devices (one specimen only,measured using test method specified in ISO 3744 in CPAP mode at 10cmH₂O).

A-weighted sound pressure Year RPT Device name level dB(A) (approx.)C-Series Tango ™ 31.9 2007 C-Series Tango ™ with Humidifier 33.1 2007 S8Escape ™ II 30.5 2005 S8 Escape ™ II with H4i ™ Humidifier 31.1 2005 S9AutoSet ™ 26.5 2010 S9 AutoSet ™ with H5i Humidifier 28.6 2010

One known RPT device used for treating sleep disordered breathing is theS9 Sleep Therapy System, manufactured by ResMed Limited. Another exampleof an RPT device is a ventilator. Ventilators such as the ResMedStellar™ Series of Adult and Paediatric Ventilators may provide supportfor invasive and non-invasive non-dependent ventilation for a range ofpatients for treating a number of conditions such as but not limited toNMD, OHS and COPD.

The ResMed Elisée™ 150 ventilator and ResMed VS III™ ventilator mayprovide support for invasive and non-invasive dependent ventilationsuitable for adult or paediatric patients for treating a number ofconditions. These ventilators provide volumetric and barometricventilation modes with a single or double limb circuit. RPT devicestypically comprise a pressure generator, such as a motor-driven bloweror a compressed gas reservoir, and are configured to supply a flow ofair to the airway of a patient. In some cases, the flow of air may besupplied to the airway of the patient at positive pressure. The outletof the RPT device is connected via an air circuit to a patient interfacesuch as those described above.

The designer of a device may be presented with an infinite number ofchoices to make. Design criteria often conflict, meaning that certaindesign choices are far from routine or inevitable. Furthermore, thecomfort and efficacy of certain aspects may be highly sensitive tosmall, subtle changes in one or more parameters.

2.2.3.3 Humidifier

Delivery of a flow of air without humidification may cause drying ofairways. The use of a humidifier with an RPT device and the patientinterface produces humidified gas that minimizes drying of the nasalmucosa and increases patient airway comfort. In addition in coolerclimates, warm air applied generally to the face area in and about thepatient interface is more comfortable than cold air.

A range of artificial humidification devices and systems are known,however they may not fulfil the specialised requirements of a medicalhumidifier.

Medical humidifiers are used to increase humidity and/or temperature ofthe flow of air in relation to ambient air when required, typicallywhere the patient may be asleep or resting (e.g. at a hospital). Amedical humidifier for bedside placement may be small. A medicalhumidifier may be configured to only humidify and/or heat the flow ofair delivered to the patient without humidifying and/or heating thepatient's surroundings. Room-based systems (e.g. a sauna, an airconditioner, or an evaporative cooler), for example, may also humidifyair that is breathed in by the patient, however those systems would alsohumidify and/or heat the entire room, which may cause discomfort to theoccupants. Furthermore medical humidifiers may have more stringentsafety constraints than industrial humidifiers.

While a number of medical humidifiers are known, they can suffer fromone or more shortcomings. Some medical humidifiers may provideinadequate humidification, some are difficult or inconvenient to use bypatients.

2.2.3.4 Data Management

There may be clinical reasons to obtain data to determine whether thepatient prescribed with respiratory therapy has been “compliant”, e.g.that the patient has used their RPT device according to certain a“compliance rule”. One example of a compliance rule for CPAP therapy isthat a patient, in order to be deemed compliant, is required to use theRPT device for at least four hours a night for at least 21 of 30consecutive days. In order to determine a patient's compliance, aprovider of the RPT device, such as a health care provider, may manuallyobtain data describing the patient's therapy using the RPT device,calculate the usage over a predetermined time period, and compare withthe compliance rule. Once the health care provider has determined thatthe patient has used their RPT device according to the compliance rule,the health care provider may notify a third party that the patient iscompliant.

There may be other aspects of a patient's therapy that would benefitfrom communication of therapy data to a third party or external system.

Existing processes to communicate and manage such data can be one ormore of costly, time-consuming, and error-prone.

2.2.3.5 Mandibular Repositioning

A mandibular repositioning device (MRD) or mandibular advancement device(MAD) is one of the treatment options for sleep apnea and snoring. It isan adjustable oral appliance available from a dentist or other supplierthat holds the lower jaw (mandible) in a forward position during sleep.The MRD is a removable device that a patient inserts into their mouthprior to going to sleep and removes following sleep. Thus, the MRD isnot designed to be worn all of the time. The MRD may be custom made orproduced in a standard form and includes a bite impression portiondesigned to allow fitting to a patient's teeth. This mechanicalprotrusion of the lower jaw expands the space behind the tongue, putstension on the pharyngeal walls to reduce collapse of the airway anddiminishes palate vibration.

In certain examples a mandibular advancement device may comprise anupper splint that is intended to engage with or fit over teeth on theupper jaw or maxilla and a lower splint that is intended to engage withor fit over teeth on the upper jaw or mandible. The upper and lowersplints are connected together laterally via a pair of connecting rods.The pair of connecting rods are fixed symmetrically on the upper splintand on the lower splint.

In such a design the length of the connecting rods is selected such thatwhen the MRD is placed in a patient's mouth the mandible is held in anadvanced position. The length of the connecting rods may be adjusted tochange the level of protrusion of the mandible. A dentist may determinea level of protrusion for the mandible that will determine the length ofthe connecting rods.

Some MRDs are structured to push the mandible forward relative to themaxilla while other MADs, such as the ResMed Narval CC™ MRD are designedto retain the mandible in a forward position. This device also reducesor minimises dental and temporo-mandibular joint (TMJ) side effects.Thus, it is configured to minimises or prevent any movement of one ormore of the teeth.

2.2.3.6 Vent Technologies

Some forms of treatment systems may include a vent to allow the washoutof exhaled carbon dioxide. The vent may allow a flow of gas from aninterior space of a patient interface, e.g., the plenum chamber, to anexterior of the patient interface, e.g., to ambient.

The vent may comprise an orifice and gas may flow through the orifice inuse of the mask. Many such vents are noisy. Others may become blocked inuse and thus provide insufficient washout. Some vents may be disruptiveof the sleep of a bed partner 1100 of the patient 1000, e.g. throughnoise or focused airflow.

ResMed Limited has developed a number of improved mask venttechnologies. See International Patent Application Publication No. WO1998/034,665; International Patent Application Publication No. WO2000/078,381; U.S. Pat. No. 6,581,594; US Patent Application PublicationNo. US 2009/0050156; US Patent Application Publication No. 2009/0044808.

Table of noise of prior masks (ISO 17510-2:2007, 10 cmH₂O pressure at 1m)

A-weighted A-weighted sound power sound pressure level dB(A) dB(A) YearMask name Mask type (uncertainty) (uncertainty) (approx.) Glue-on (*)nasal 50.9   42.9   1981 ResCare nasal 31.5   23.5   1993 standard (*)ResMed nasal 29.5   21.5   1998 Mirage ™ (*) ResMed nasal 36 (3) 28 (3)2000 UltraMirage ™ ResMed nasal 32 (3) 24 (3) 2002 Mirage Activa ™ResMed nasal 30 (3) 22 (3) 2008 Mirage Micro ™ ResMed nasal 29 (3) 22(3) 2008 Mirage ™ SoftGel ResMed nasal 26 (3) 18 (3) 2010 Mirage ™ FXResMed nasal pillows 37   29   2004 Mirage Swift ™ (*) ResMed nasalpillows 28 (3) 20 (3) 2005 Mirage Swift ™ II ResMed nasal pillows 25 (3)17 (3) 2008 Mirage Swift ™ LT ResMed AirFit P10 nasal pillows 21 (3) 13(3) 2014 (* one specimen only, measured using test method specified inISO 3744 in CPAP mode at 10 cmH₂O)

Sound pressure values of a variety of objects are listed below

A-weighted sound pressure Object dB(A) Notes Vacuum cleaner: Nilfisk 68ISO 3744 at Walter Broadly Litter Hog: 1 m distance B+ GradeConversational speech 60 1 m distance Average home 50 Quiet library 40Quiet bedroom at night 30 Background in TV studio 20

2.2.4 Diagnosis and Monitoring Systems

Polysomnography (PSG) is a conventional system for diagnosis andmonitoring of cardio-pulmonary disorders, and typically involves expertclinical staff to apply the system. PSG typically involves the placementof 15 to 20 contact sensors on a patient in order to record variousbodily signals such as electroencephalography (EEG), electrocardiography(ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG forsleep disordered breathing has involved two nights of observation of apatient in a clinic, one night of pure diagnosis and a second night oftitration of treatment parameters by a clinician. PSG is thereforeexpensive and inconvenient. In particular it is unsuitable for homesleep testing.

Clinical experts may be able to diagnose or monitor patients adequatelybased on visual observation of PSG signals. However, there arecircumstances where a clinical expert may not be available, or aclinical expert may not be affordable. Different clinical experts maydisagree on a patient's condition. In addition, a given clinical expertmay apply a different standard at different times.

3 BRIEF SUMMARY OF THE TECHNOLOGY

The present technology is directed towards providing medical devicesused in the diagnosis, amelioration, treatment, or prevention ofrespiratory disorders having one or more of improved comfort, cost,efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to apparatus used inthe diagnosis, amelioration, treatment or prevention of a respiratorydisorder.

Another aspect of the present technology relates to methods used in thediagnosis, amelioration, treatment or prevention of a respiratorydisorder.

An aspect of certain forms of the present technology is to providemethods and/or apparatus that improve the compliance of patients withrespiratory therapy.

An aspect of the present technology relates to a humidifier including awater reservoir comprising a non-metallic, thin film base adapted tothermally engage with a heater plate. The thin film base of the waterreservoir is structured to provide an arrangement that reduces cost ofproduction of the water reservoir, while retaining, or improving, itsheat transfer characteristics as well as its reliability. In an example,the thin film base may be sufficiently thin and flat to provide goodthermal contact and good humidifier performance and allow a suitablematerial to be selected, e.g., depending on humidifier requirements andperformance.

An aspect of the present technology relates to a water reservoir for anapparatus for humidifying a flow of breathable gas including a reservoirbase including a cavity structured to hold a volume of liquid and aconductive portion provided to the base. The conductive portion isadapted to thermally engage with a heater plate to allow thermaltransfer of heat from the heater plate to the volume of liquid. Theconductive portion includes a thin film comprising a non-metallicmaterial, and the thin film includes a wall thickness less than about 1mm.

In an example, the wall thickness of the thin film may be less thanabout 0.5 mm. In an example, the thin film may comprise silicone,polycarbonate, or other thermoplastic or elastomeric materials. In anexample, the thin film may be provided as a separate and distinctstructure from the reservoir base. In an example, the thin filmcomprises a pre-formed structure that is secured or otherwise providedto the reservoir base. In an example, the reservoir base may include ahole structured to receive the thin film. In an example, the thin filmmay include a shape that corresponds to a shape of the hole. In anexample, the thin film may be generally planar. In an example, the thinfilm may include a first side adapted to form a bottom interior surfaceof the water reservoir exposed to the volume of liquid and a secondside, opposite to the first side, adapted to form a bottom exteriorsurface of the water reservoir exposed to the heater plate. In anexample, the second side of the thin film may provide a contact surfacestructured and arranged to directly engage with the heater plate. In anexample, the non-metallic material of the thin film may be similar to amaterial of the reservoir base. In an example, the wall thickness of thethin film may be less than a wall thickness of walls of the reservoirbase. In an example, the water reservoir may further comprise one ormore ribs structured and arranged to extend across the thin film so asto create a force adapted to push the thin film against the heaterplate. In an example, the reservoir base may include a base upper body,a base bottom plate, and the thin film which together form the cavity.In an example, the water reservoir may further comprise a reservoir lidmovably connected to the reservoir base to allow the water reservoir tobe convertible between an open configuration and a closed configuration.

Another aspect of the present technology relates to a water reservoirfor an apparatus for humidifying a flow of breathable gas including areservoir base including a cavity structured to hold a volume of liquidand a conductive portion provided to the base. The conductive portion isadapted to thermally engage with a heater plate to allow thermaltransfer of heat from the heater plate to the volume of liquid. Theconductive portion includes a thin film comprising a non-metallicmaterial. The thin film is provided as a separate and distinct structurefrom the reservoir base, and the thin film includes a wall thicknessthat is less than a wall thickness of walls of the reservoir base. In anexample, the thin film may comprise a pre-formed structure that issecured or otherwise provided to the reservoir base.

An aspect of one form of the present technology is a method ofmanufacturing apparatus.

An aspect of certain forms of the present technology is a medical devicethat is easy to use, e.g. by a person who does not have medicaltraining, by a person who has limited dexterity, vision or by a personwith limited experience in using this type of medical device.

An aspect of one form of the present technology is a patient interfacethat may be washed in a home of a patient, e.g., in soapy water, withoutrequiring specialised cleaning equipment. An aspect of one form of thepresent technology is a humidifier tank that may be washed in a home ofa patient, e.g., in soapy water, without requiring specialised cleaningequipment.

The methods, systems, devices and apparatus described herein can provideimproved functioning in a processor, such as of a processor of aspecific purpose computer, respiratory monitor and/or a respiratorytherapy apparatus. Moreover, the described methods, systems, devices andapparatus can provide improvements in the technological field ofautomated management, monitoring and/or treatment of respiratoryconditions, including, for example, sleep disordered breathing.

Of course, portions of the aspects may form sub-aspects of the presenttechnology. Also, various ones of the sub-aspects and/or aspects may becombined in various manners and also constitute additional aspects orsub-aspects of the present technology.

Other features of the technology will be apparent from consideration ofthe information contained in the following detailed description,abstract, drawings and claims.

4 BRIEF DESCRIPTION OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

4.1 Treatment Systems

FIG. 1A shows a system including a patient 1000 wearing a patientinterface 3000, in the form of nasal pillows, receiving a supply of airat positive pressure from an RPT device 4000. Air from the RPT device4000 is humidified in a humidifier 5000, and passes along an air circuit4170 to the patient 1000. A bed partner 1100 is also shown. The patientis sleeping in a supine sleeping position.

FIG. 1B shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a nasal mask, receiving a supply of airat positive pressure from an RPT device 4000. Air from the RPT device ishumidified in a humidifier 5000, and passes along an air circuit 4170 tothe patient 1000.

FIG. 1C shows a system including a patient 1000 wearing a patientinterface 3000, in the form of a full-face mask, receiving a supply ofair at positive pressure from an RPT device 4000. Air from the RPTdevice is humidified in a humidifier 5000, and passes along an aircircuit 4170 to the patient 1000. The patient is sleeping in a sidesleeping position.

4.2 Respiratory System and Facial Anatomy

FIG. 2A shows an overview of a human respiratory system including thenasal and oral cavities, the larynx, vocal folds, oesophagus, trachea,bronchus, lung, alveolar sacs, heart and diaphragm.

FIG. 2B shows a view of a human upper airway including the nasal cavity,nasal bone, lateral nasal cartilage, greater alar cartilage, nostril,lip superior, lip inferior, larynx, hard palate, soft palate,oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

4.3 Patient Interface

FIG. 3A shows a patient interface in the form of a nasal mask inaccordance with one form of the present technology.

FIG. 3B shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a positive sign, and a relatively large magnitude whencompared to the magnitude of the curvature shown in FIG. 3C.

FIG. 3C shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a positive sign, and a relatively small magnitude whencompared to the magnitude of the curvature shown in FIG. 3B.

FIG. 3D shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a value of zero.

FIG. 3E shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a negative sign, and a relatively small magnitude whencompared to the magnitude of the curvature shown in FIG. 3F.

FIG. 3F shows a schematic of a cross-section through a structure at apoint. An outward normal at the point is indicated. The curvature at thepoint has a negative sign, and a relatively large magnitude whencompared to the magnitude of the curvature shown in FIG. 3E.

FIG. 3G shows a cushion for a mask that includes two pillows. Anexterior surface of the cushion is indicated. An edge of the surface isindicated. Dome and saddle regions are indicated.

FIG. 3H shows a cushion for a mask. An exterior surface of the cushionis indicated. An edge of the surface is indicated. A path on the surfacebetween points A and B is indicated. A straight line distance between Aand B is indicated. Two saddle regions and a dome region are indicated.

FIG. 3I shows the surface of a structure, with a one dimensional hole inthe surface. The illustrated plane curve forms the boundary of a onedimensional hole.

FIG. 3J shows a cross-section through the structure of FIG. 3I. Theillustrated surface bounds a two dimensional hole in the structure ofFIG. 3I.

FIG. 3K shows a perspective view of the structure of FIG. 3I, includingthe two dimensional hole and the one dimensional hole. Also shown is thesurface that bounds a two dimensional hole in the structure of FIG. 3I.

FIG. 3L shows a mask having an inflatable bladder as a cushion.

FIG. 3M shows a cross-section through the mask of FIG. 3L, and shows theinterior surface of the bladder. The interior surface bounds the twodimensional hole in the mask.

FIG. 3N shows a further cross-section through the mask of FIG. 3L. Theinterior surface is also indicated.

FIG. 3O illustrates a left-hand rule.

FIG. 3P illustrates a right-hand rule.

FIG. 3Q shows a left ear, including the left ear helix.

FIG. 3R shows a right ear, including the right ear helix.

FIG. 3S shows a right-hand helix.

FIG. 3T shows a view of a mask, including the sign of the torsion of thespace curve defined by the edge of the sealing membrane in differentregions of the mask.

4.4 RPT Device

FIG. 4A shows an RPT device in accordance with one form of the presenttechnology.

4.5 Humidifier

FIG. 5 is a perspective view of an RPT device and an integratedhumidifier according to an example of the present technology, anddemonstrating engagement of the humidifier with the air circuitaccording to an example of the present technology.

FIG. 6 is a perspective view of the RPT device and integrated humidifierof FIG. 5 demonstrating engagement of the humidifier reservoir with thereservoir dock according to an example of the present technology.

FIG. 7 is another perspective view of the RPT device and integratedhumidifier of FIG. 5.

FIG. 8 is another perspective view of the RPT device and integratedhumidifier of FIG. 5 demonstrating engagement of the humidifierreservoir with the reservoir dock according to an example of the presenttechnology.

FIG. 9 to 12 show various views of a humidifier reservoir according toan example of present technology, wherein FIGS. 9 to 11 show thehumidifier reservoir in a closed configuration and FIG. 12 shows thehumidifier reservoir in an open configuration.

FIG. 13 is a top perspective view of a reservoir base of a humidifierreservoir according to an example of present technology.

FIG. 14 is a bottom perspective view of the reservoir base of FIG. 13.

FIG. 15 is an exploded view of the reservoir base of FIG. 13.

FIG. 16 is a cross-sectional view of a humidifier reservoir includingthe reservoir base of FIG. 13 according to an example of presenttechnology.

FIG. 17 is a cross-sectional view of a base bottom plate and conductiveportion of the reservoir base of FIG. 13 according to an example ofpresent technology.

FIG. 18 is a top perspective view of a reservoir base of a humidifierreservoir according to another example of present technology.

FIG. 19 is a bottom perspective view of the reservoir base of FIG. 18.

FIG. 20 is a cross-sectional view of a base bottom plate and conductiveportion of the reservoir base of FIG. 18 according to an example ofpresent technology.

FIG. 21 shows a schematic of a humidifier in accordance with one form ofthe present technology.

5 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

The following description is provided in relation to various exampleswhich may share one or more common characteristics and/or features. Itis to be understood that one or more features of any one example may becombinable with one or more features of another example or otherexamples. In addition, any single feature or combination of features inany of the examples may constitute a further example.

5.1 Therapy

In one form, the present technology comprises a method for treating arespiratory disorder comprising the step of applying positive pressureto the entrance of the airways of a patient 1000.

In certain examples of the present technology, a supply of air atpositive pressure is provided to the nasal passages of the patient viaone or both nares.

In certain examples of the present technology, mouth breathing islimited, restricted or prevented.

5.2 Treatment Systems

In one form, the present technology comprises an apparatus or device fortreating a respiratory disorder. The apparatus or device may comprise anRPT device 4000 for supplying pressurised air to the patient 1000 via anair circuit 4170 to a patient interface 3000, e.g., see FIGS. 1A to 1C.

5.3 Patient Interface

As shown in FIG. 3A, a non-invasive patient interface 3000 in accordancewith one aspect of the present technology comprises the followingfunctional aspects: a seal-forming structure 3100, a plenum chamber3200, a positioning and stabilising structure 3300, a vent 3400, oneform of connection port 3600 for connection to air circuit 4170, and aforehead support 3700. In some forms a functional aspect may be providedby one or more physical components. In some forms, one physicalcomponent may provide one or more functional aspects. In use theseal-forming structure 3100 is arranged to surround an entrance to theairways of the patient so as to facilitate the supply of air at positivepressure to the airways.

If a patient interface is unable to comfortably deliver a minimum levelof positive pressure to the airways, the patient interface may beunsuitable for respiratory pressure therapy.

The patient interface 3000 in accordance with one form of the presenttechnology is constructed and arranged to be able to provide a supply ofair at a positive pressure of at least 6 cmH₂O with respect to ambient.

The patient interface 3000 in accordance with one form of the presenttechnology is constructed and arranged to be able to provide a supply ofair at a positive pressure of at least 10 cmH₂O with respect to ambient.

The patient interface 3000 in accordance with one form of the presenttechnology is constructed and arranged to be able to provide a supply ofair at a positive pressure of at least 20 cmH₂O with respect to ambient.

5.4 RPT Device

An RPT device 4000 in accordance with one aspect of the presenttechnology comprises mechanical, pneumatic, and/or electrical componentsand is configured to execute one or more algorithms, e.g., see FIG. 4A.The RPT device 4000 may be configured to generate a flow of air fordelivery to a patient's airways, such as to treat one or more of therespiratory conditions described elsewhere in the present document.

In one form, the RPT device 4000 is constructed and arranged to becapable of delivering a flow of air in a range of −20 L/min to +150L/min while maintaining a positive pressure of at least 6 cmH₂O, or atleast 10cmH₂O, or at least 20 cmH₂O.

A power supply may be located internal or external of the externalhousing of the RPT device 4000.

In one form of the present technology, power supply provides electricalpower to the RPT device only. In another form of the present technology,power supply provides electrical power to both RPT device 4000 andhumidifier 5000.

In one form of the present technology, the RPT device 4000 includes acentral controller including one or a plurality of processors suitableto control an RPT device 4000.

Suitable processors may include an x86 INTEL processor, a processorbased on ARM® Cortex®-M processor from ARM Holdings such as an STM32series microcontroller from ST MICROELECTRONIC. In certain alternativeforms of the present technology, a 32-bit RISC CPU, such as an STR9series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPUsuch as a processor from the MSP430 family of microcontrollers,manufactured by TEXAS INSTRUMENTS may also be suitable.

In one form of the present technology, the central controller is adedicated electronic circuit.

In one form, the central controller is an application-specificintegrated circuit. In another form, the central controller comprisesdiscrete electronic components.

The central controller may be configured to receive input signal(s) fromone or more transducers, one or more input devices, and the humidifier5000.

The central controller may be configured to provide output signal(s) toone or more of an output device, a therapy device controller, a datacommunication interface, and the humidifier 5000.

In some forms of the present technology, the central controller isconfigured to implement the one or more methodologies described herein,such as the one or more algorithms expressed as computer programs storedin a non-transitory computer readable storage medium, such as memory. Insome forms of the present technology, the central controller may beintegrated with an RPT device 4000. However, in some forms of thepresent technology, some methodologies may be performed by a remotelylocated device. For example, the remotely located device may determinecontrol settings for a ventilator or detect respiratory related eventsby analysis of stored data such as from any of the sensors describedherein.

5.5 Air Circuit

An air circuit 4170 in accordance with an aspect of the presenttechnology is a conduit or a tube constructed and arranged to allow, inuse, a flow of air to travel between two components such as RPT device4000 and the patient interface 3000.

In particular, the air circuit 4170 may be in fluid connection with theoutlet of the pneumatic block and the patient interface. The air circuitmay be referred to as an air delivery tube. In some cases there may beseparate limbs of the circuit for inhalation and exhalation. In othercases a single limb is used.

In some forms, the air circuit 4170 may comprise one or more heatingelements configured to heat air in the air circuit, for example tomaintain or raise the temperature of the air. The heating element may bein a form of a heated wire circuit, and may comprise one or moretransducers, such as temperature sensors. In one form, the heated wirecircuit may be helically wound around the axis of the air circuit 4170.The heating element may be in communication with a controller such as acentral controller. One example of an air circuit 4170 comprising aheated wire circuit is described in U.S. Pat. No. 8,733,349, which isincorporated herewithin in its entirety by reference.

5.6 Humidifier 5.6.1 Humidifier Overview

In one form of the present technology there is provided a humidifier tochange the absolute humidity of air or gas for delivery to a patientrelative to ambient air. Typically, the humidifier is used to increasethe absolute humidity and increase the temperature of the flow of air(relative to ambient air) before delivery to the patient's airways.

FIGS. 5 to 8 show a RPT device 4000 and an integrated humidifier 5000according to an example of the present technology. In the illustratedexample, the humidifier 5000 includes a water reservoir dock 5130structured to receive a water reservoir 5110. As shown, the waterreservoir dock 5130 includes a cavity 5160 formed therein to receive thewater reservoir 5110, e.g., the water reservoir 5110 may beinsertable/removable from the water reservoir dock 5110 in a lateraldirection.

In the illustrated example, the RPT device 4000 is integrated with thehumidifier 5000. As this arrangement, the water reservoir dock 5130 isstructured to connect the water reservoir 5110 to the pneumatic path. Asbest shown in FIGS. 5 and 8, the reservoir dock 5130 comprises a dockair outlet 5168 to deliver a flow of air to the water reservoir 5110, adock air inlet 5170 to receive the flow of air that has been humidifiedin the water reservoir 5110, and a humidifier outlet 5172 to transferthe flow of humidified air to the air circuit 4170. The cavity 5160 mayinclude a top portion configured to cover at least a portion of the lidof the water reservoir 5110 and a bottom portion including a heaterplate 5120.

However, it should be appreciated that the reservoir dock 5130 may beprovided separately to RPT device 4000 in an alternative arrangement. Insuch an arrangement, additional interfaces may be used to connect thereservoir dock 5130 to the RPT device 4000, e.g., directly coupled orcoupled via an air circuit.

In another arrangement, the water reservoir dock 5130 may comprise anopening in a substantially horizontal plane, so that the water reservoir5110 may be inserted from above or below the water reservoir dock 5130.

Further examples and details of such RPT device 4000 and integratedhumidifier 5000 are described in PCT Publication No. WO 2014/138804,published Sep. 18, 2014, which is incorporated herein by reference inits entirety.

5.6.2 Humidifier Components 5.6.2.1 Water Reservoir

FIGS. 9 to 12 show one form of a water reservoir or tub 5110, whichcomprises a reservoir base 5112, a reservoir lid 5114, and anintermediate portion including a compliant portion 5116. The waterreservoir 5110 includes a cavity (e.g., provided by the base) configuredto hold, or retain, a volume of liquid (e.g. water) to be evaporated forhumidification of the flow of air. The water reservoir 5110 may beconfigured to hold a predetermined maximum volume of water in order toprovide adequate humidification for at least the duration of arespiratory therapy session, such as one evening of sleep. Typically,the reservoir 5110 is configured to hold several hundred millilitres ofwater, e.g. 300 millilitres (ml), 325 ml, 350 ml or 400 ml. In otherforms, the humidifier 5000 may be configured to receive a supply ofwater from an external water source such as a building's water supplysystem.

According to one aspect, the water reservoir 5110 is configured to addhumidity to a flow of air from the RPT device 4000 as the flow of airtravels therethrough. In one form, the water reservoir 5110 may beconfigured to encourage the flow of air to travel in a tortuous paththrough the reservoir 5110 while in contact with the volume of watertherein.

The reservoir 5110 may also be configured to discourage egress of liquidtherefrom, such as when the reservoir 5110 is displaced and/or rotatedfrom its normal, working orientation, such as through any aperturesand/or in between its sub-components. As the flow of air to behumidified by the humidifier 5000 is typically pressurised, thereservoir 5110 may also be configured to prevent losses in pneumaticpressure through leak and/or flow impedance.

In the illustrated example, the reservoir lid 5114 comprises an inlet5118 for receiving the flow of air into the reservoir 5110 and an outlet5122 for delivering a flow of air from the reservoir 5110. The reservoirlid 5114 is pivotably connected to the base 5112 by hinges 5158 to allowthe reservoir 5110 to be converted between a closed configuration, asshown in FIGS. 9 to 11, and an open configuration, as shown in FIG. 12.When the water reservoir 5110 is in its closed configuration, thecompliant portion 5116 is put into sealing engagement between the base5112 and the lid 5114 to seal the base 5112 and the lid 5114 and preventegress of water from the reservoir 5110. The compliant portion 5116 mayalso perform other functions, such as to improve thermal contact betweenthe reservoir 5110 and the heater plate 5120.

The reservoir base 5112 may be configured as a receptacle to retain thegiven, maximum volume of liquid that the reservoir 5110 is configured tohold. In one form, the base 5112 may comprise further features such asan overfill prevention feature, e.g., at least one orifice 5138 in thewater reservoir 5110 to indicate over-filling as shown in FIG. 13

In one form, the reservoir base 5112 may further comprise an inner lip5224 and/or an outer lip 5226, for example as shown in FIG. 13.According to one aspect, the inner lip 5224 and/or outer lip 5226 mayprevent egress of liquid from the reservoir 5110 through the interfacebetween an intermediate portion (e.g. the compliant portion 5116) andthe base 5112, for example when the intermediate portion is compressed,or when the intermediate portion is under vibration.

In one form, the reservoir base 5112 includes a base upper body 5146, abase bottom plate 5148, and a conductive portion 5152 which togetherform a receptacle, e.g., see FIG. 15. However, it should be appreciatedthat the reservoir base 5112 may be constructed in any number of parts.

In an example, the base upper body 5146, the base bottom plate 5148and/or the lid 5114 may be constructed from a bio-compatible materialsuitable for retaining the volume of liquid, such as a plastic orthermoplastic polymer, for example, acrylonitrile butadiene styrene(ABS) or polycarbonate material.

In an example, a sealing element may be provided, e.g., between the baseupper body 5146 and the base bottom plate 5148, to prevent egress ofwater from the water reservoir 5110, particularly from the base 5112.

Further examples and details of such water reservoir are described inPCT Publication No. WO 2014/138804, published Sep. 18, 2014, which isincorporated herein by reference in its entirety.

5.6.2.2 Conductive Portion

According to an example of the present technology, the reservoir 5110comprises a conductive portion 5152 configured to allow efficienttransfer of heat from the heater plate 5120 to the volume of liquid inthe reservoir 5110. The conductive portion 5152 comprises a heatconducting material structured and arranged for thermal engagement orcontact with the heater plate 5120 so as to allow thermal transfer ofheat from the heater plate to the volume of liquid.

In the illustrated example of FIGS. 13 to 20, the conductive portion5152 comprises a thin film (also referred to as a film base or a baseconductor film) comprising a thermally conductive, non-metallic materialconfigured to thermally couple with the heater plate 5120 of thehumidifier 5000.

In an example, the heat conducting, non-metallic material of the thinfilm 5152 may comprise silicone, polycarbonate, or other thermoplasticor elastomeric materials.

In an example, the thin film 5152 may comprise a thickness of about 0.05mm to 1.5 mm, e.g., 0.10 mm to 0.125 mm. In an example, the thin filmmay comprise a thickness less than about 1 mm, e.g., less than about 0.5mm. In one form the film may comprise a silicone (LSR) film having athickness of about 0.4 mm.

In the illustrated example, the base bottom plate 5148 includes sidewalls 5149.1 extending around the perimeter of the base bottom plate anda bottom wall 5149.2 that joins the side walls 5149.1, e.g., see FIG.17. The thin film 5152 is provided or otherwise incorporated into thebottom wall 5149.2 to form the receptacle for retaining liquid. In theillustrated example, the bottom wall 5149.2 includes a hole 5149.3structured to receive the thin film 5152, e.g., see FIG. 15. The thinfilm 5152 is sealingly secured within and/or across the hole 5149.3 inan operative position so as to form at least a portion of the base ofthe receptacle and prevent egress of water from the water reservoir5110.

For example, the thin film 5152 may include a shape that corresponds tothe shape of the hole 5149.3 such that the interior surface bounding thehole 5149.3 is secured against edges at the perimeter of the thin film5152. Alternatively, the thin film 5152 may include a shape that isdifferent than the shape of the hole 5149.3 such that the edges at theperimeter of the thin film 5152 extend beyond edges of the hole 5149.3,e.g., thin film 5152 overlaps bottom wall 5149.2 of the base bottomplate 5148. In the illustrated example, the thin film 5152 includes ashape that generally corresponds to a shape of the heater plate 5120,e.g., rectangular, however other suitable shapes are possible, e.g.,square, circular, oval.

As illustrated, the thin film 5152 includes a first side 5152.1 adaptedto form a bottom interior surface of the reservoir 5110 exposed to thewater. The thin film 5152 includes a second side 5152.2, opposite to thefirst side 5152.1, adapted to form a bottom exterior surface of thereservoir 5110 exposed to the heater plate 5120, e.g., second side5152.2 of the thin film 5152 provides a contact surface structured andarranged to directly engage with the heater plate 5120.

In the illustrated example, the thin film 5152 is generally planar andprovided at the bottom of the reservoir. However, the thin film 5152 maycomprise a non-planar shape and may be provided in other regions of thereservoir, e.g., provided along a side wall of the reservoir exposed tothe water. In an example, the thin film 5152 may overlap one or morewalls of the base bottom plate 5148, e.g., thin film extends across holein the base bottom plate and shaped to conform and overlap with bottomand/or side walls of the base bottom plate 5148.

In an example, the film 5152 is provided as a separate and distinctstructure from the base bottom plate 5148 and then secured or otherwiseprovided to the base bottom plate 5148 in an operative position, e.g.,film 5152 comprises a pre-formed structure that is secured to the basebottom plate 5148.

In an example, the film 5152 may be pre-formed, and then insert mouldedto the base bottom plate 5148. In another example, the film 5152 may bepre-formed and then secured to the base bottom plate 5148, e.g., byadhesives or welding. In yet another example, the film 5152 may beprovided to the base bottom plate 5148 by overmoulding the film 5152 tothe base bottom plate 5148.

In an example, the base bottom plate 5148 may be eliminated, or the filmmay be supported or reinforced in other ways, e.g., at least onereinforcing strip of a more rigid material compared to the film,embedded into or otherwise provided to the film. In an example, the filmmay be provided to the base upper body 5146 such that the filmconstitutes the entire bottom of the reservoir.

In arrangements where a pre-formed film 5152 is provided to the basebottom plate 5148 (e.g., insert-moulded or adhered), the film maycomprise a thermoplastic polycarbonate film material (e.g., Makrofol DE1-4 material of about 0.1 mm thickness), and the base bottom plate 5148may comprise a thermoplastic polycarbonate material (e.g., Makrolon 2458(or Makrolon 2258) material). However, it should be appreciated that thepre-formed film and/or the base bottom plate may comprise other suitablematerials.

In an example, the film may be filled with one or more additives topromote thermal conductivity, in which case the film may be thicker,e.g., for added mechanical stability.

For example, the film may comprise ceramic powder or metallic powderfilled plastics, or the film may comprise multiple films or layers,e.g., sandwich laminates including a metallic film with a plastic filmon one or both sides of the metallic film.

In an example, powder-coating or spray painting with thermallyconductive materials (e.g., metals) may be applied to the second side5152.2 of the film facing the heater plate 5120 to improve thermalconductivity.

In an example, the film 5152 may comprise a thickness that is differentthan a thickness of the bottom and/or side walls of the base bottomplate 5148, e.g., wall thickness of the film is less than the wallthickness of the bottom and/or side walls of the base bottom plate 5148.Such arrangement allows the thickness of the film to be suitablyselected to achieve desired performance characteristics, e.g.,performance at high flows, humidification rate, heat-up time.

In an example, the film 5152 may comprise a material similar to thematerial of the base upper body 5146 and/or the base bottom plate, withthe film 5152 comprising a wall thickness that is less than a wallthickness of walls of the base upper body 5146 and/or the base bottomplate 5148.

In an example, as shown in FIGS. 18 to 20, the reservoir 5110 may beprovided with one or more ribs 5175 structured and arranged to extendacross the thin film 5152 so as to create a force adapted to push thethin film 5152 against the heater plate 5120.

Alternatively or in addition, the humidifier may be provided with aspring-like element structured and arranged to push the heater plate5120 against the thin film 5152.

The thin film base 5152 of the reservoir provides an arrangement thatreduces cost of production of the reservoir, while retaining, orimproving, its heat transfer characteristics as well as its reliability.For example, the thin film base is advantageous in that the thin filmbase may be sufficiently thin and flat to provide good thermal contactand good humidifier performance and allow a suitable material to beselected, e.g., depending on humidifier requirements and performance.

In an example, the thin film base may be advantageous in that thenon-metallic properties of the thin film base (e.g., thermoplastic orelastomeric material properties) provides corrosion protection (e.g.,protection due to exposure to water) and a sealed connection with thebase bottom plate 5148 (e.g., to form a sealed reservoir for thehumidification water). Also, the non-metallic properties of the thinfilm base (e.g., thermoplastic or elastomeric material properties) mayfacilitate manufacture of the thin film base to assume complex shapes,e.g., thin film base may be molded into complex shapes if required tomeet design requirements of the humidifier. Further, the reduced cost ofproduction of the reservoir is particularly desirable in the case of adisposable reservoir in which the reservoir is intended only for alimited product life where a hospital, a patient or a user replaces thereservoir on a regular basis.

5.6.2.3 Humidifier Reservoir Dock

As described above, the humidifier 5000 may comprise a humidifierreservoir dock 5130 (as shown in FIGS. 5 to 8) configured to receive thehumidifier reservoir 5110. In some arrangements, the humidifierreservoir dock 5130 may comprise a locking feature configured to retainthe reservoir 5110 in the humidifier reservoir dock 5130.

5.6.2.4 Water Level Indicator

The humidifier reservoir 5110 may comprise a water level indicator. Insome forms, the water level indicator may provide one or moreindications to a user such as the patient 1000 or a care giver regardinga quantity of the volume of water in the humidifier reservoir 5110. Theone or more indications provided by the water level indicator mayinclude an indication of a maximum, predetermined volume of water, anyportions thereof, such as 25%, 50% or 75% or volumes such as 200 ml, 300ml or 400 ml.

5.6.2.5 Humidifier Transducer(s)

As shown in FIG. 21, the humidifier 5000 may comprise one or morehumidifier transducers (sensors) 5210 instead of, or in addition to,transducers provided in the RPT device 4000. Humidifier transducers 5210may include one or more of an air pressure sensor 5212, an air flow ratetransducer 5214, a temperature sensor 5216, or a humidity sensor 5218 asshown in FIG. 21. A humidifier transducer 5210 may produce one or moreoutput signals which may be communicated to a controller such as acentral controller of the RPT device 4000 and/or a central humidifiercontroller 5250. In some forms, a humidifier transducer may be locatedexternally to the humidifier 5000 (such as in the air circuit 4170)while communicating the output signal to the controller.

5.6.2.5.1 Pressure Transducer

One or more pressure transducers 5212 may be provided to the humidifier5000 in addition to, or instead of, a pressure sensor provided in theRPT device 4000.

5.6.2.5.2 Flow Rate Transducer

One or more flow rate transducers 5214 may be provided to the humidifier5000 in addition to, or instead of, a flow rate sensor provided in theRPT device 4000.

5.6.2.5.3 Temperature Transducer

The humidifier 5000 may comprise one or more temperature transducers5216. The one or more temperature transducers 5216 may be configured tomeasure one or more temperatures such as of the heating element 5240and/or of the flow of air downstream of the humidifier outlet. In someforms, the humidifier 5000 may further comprise a temperature sensor5216 to detect the temperature of the ambient air.

5.6.2.5.4 Humidity Transducer

In one form, the humidifier 5000 may comprise one or more humiditysensors 5218 to detect a humidity of a gas, such as the ambient air. Thehumidity sensor 5218 may be placed towards the humidifier outlet in someforms to measure a humidity of the gas delivered from the humidifier5000. The humidity sensor may be an absolute humidity sensor or arelative humidity sensor.

5.6.2.6 Heating Element

A heating element 5240 may be provided to the humidifier 5000 in somecases to provide a heat input to one or more of the volume of water inthe humidifier reservoir 5110 and/or to the flow of air. The heatingelement 5240 may comprise a heat generating component such as anelectrically resistive heating track. One suitable example of a heatingelement 5240 is a layered heating element such as one described in thePCT Patent Application Publication No. WO 2012/171072, which isincorporated herewith by reference in its entirety.

In some forms, the heating element 5240 may be provided in thehumidifier base where heat may be provided to the humidifier reservoir5110 primarily by conduction.

5.6.2.7 Humidifier Controller

According to one arrangement of the present technology, a humidifier5000 may comprise a humidifier controller 5250 as shown in FIG. 21. Inone form, the humidifier controller 5250 may be a part of the centralcontroller of the RPT device 4000. In another form, the humidifiercontroller 5250 may be a separate controller, which may be incommunication with the central controller.

In one form, the humidifier controller 5250 may receive as inputsmeasures of properties (such as temperature, humidity, pressure and/orflow rate), for example of the flow of air, the water in the reservoir5110 and/or the humidifier 5000. The humidifier controller 5250 may alsobe configured to execute or implement humidifier algorithms and/ordeliver one or more output signals.

As shown in FIG. 21, the humidifier controller 5250 may comprise one ormore controllers, such as a central humidifier controller 5251, a heatedair circuit controller 5254 configured to control the temperature of aheated air circuit 4171 and/or a heating element controller 5252configured to control the temperature of a heating element 5240.

5.7 Glossary

For the purposes of the present technology disclosure, in certain formsof the present technology, one or more of the following definitions mayapply. In other forms of the present technology, alternative definitionsmay apply.

5.7.1 General

Air: In certain forms of the present technology, air may be taken tomean atmospheric air, and in other forms of the present technology airmay be taken to mean some other combination of breathable gases, e.g.atmospheric air enriched with oxygen.

Ambient: In certain forms of the present technology, the term ambientwill be taken to mean (i) external of the treatment system or patient,and (ii) immediately surrounding the treatment system or patient.

For example, ambient humidity with respect to a humidifier may be thehumidity of air immediately surrounding the humidifier, e.g. thehumidity in the room where a patient is sleeping. Such ambient humiditymay be different to the humidity outside the room where a patient issleeping.

In another example, ambient pressure may be the pressure immediatelysurrounding or external to the body.

In certain forms, ambient (e.g., acoustic) noise may be considered to bethe background noise level in the room where a patient is located, otherthan for example, noise generated by an RPT device or emanating from amask or patient interface. Ambient noise may be generated by sourcesoutside the room.

Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy in whichthe treatment pressure is automatically adjustable, e.g. from breath tobreath, between minimum and maximum limits, depending on the presence orabsence of indications of SDB events.

Continuous Positive Airway Pressure (CPAP) therapy: Respiratory pressuretherapy in which the treatment pressure is approximately constantthrough a respiratory cycle of a patient. In some forms, the pressure atthe entrance to the airways will be slightly higher during exhalation,and slightly lower during inhalation. In some forms, the pressure willvary between different respiratory cycles of the patient, for example,being increased in response to detection of indications of partial upperairway obstruction, and decreased in the absence of indications ofpartial upper airway obstruction.

Flow rate: The volume (or mass) of air delivered per unit time. Flowrate may refer to an instantaneous quantity. In some cases, a referenceto flow rate will be a reference to a scalar quantity, namely a quantityhaving magnitude only. In other cases, a reference to flow rate will bea reference to a vector quantity, namely a quantity having bothmagnitude and direction. Flow rate may be given the symbol Q. ‘Flowrate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.

In the example of patient respiration, a flow rate may be nominallypositive for the inspiratory portion of a breathing cycle of a patient,and hence negative for the expiratory portion of the breathing cycle ofa patient. Total flow rate, Qt, is the flow rate of air leaving the RPTdevice. Vent flow rate, Qv, is the flow rate of air leaving a vent toallow washout of exhaled gases. Leak flow rate, Ql, is the flow rate ofleak from a patient interface system or elsewhere. Respiratory flowrate, Qr, is the flow rate of air that is received into the patient'srespiratory system.

Humidifier: The word humidifier will be taken to mean a humidifyingapparatus constructed and arranged, or configured with a physicalstructure to be capable of providing a therapeutically beneficial amountof water (H₂O) vapour to a flow of air to ameliorate a medicalrespiratory condition of a patient.

Leak: The word leak will be taken to be an unintended flow of air. Inone example, leak may occur as the result of an incomplete seal betweena mask and a patient's face. In another example leak may occur in aswivel elbow to the ambient.

Noise, conducted (acoustic): Conducted noise in the present documentrefers to noise which is carried to the patient by the pneumatic path,such as the air circuit and the patient interface as well as the airtherein. In one form, conducted noise may be quantified by measuringsound pressure levels at the end of an air circuit.

Noise, radiated (acoustic): Radiated noise in the present documentrefers to noise which is carried to the patient by the ambient air. Inone form, radiated noise may be quantified by measuring soundpower/pressure levels of the object in question according to ISO 3744.

Noise, vent (acoustic): Vent noise in the present document refers tonoise which is generated by the flow of air through any vents such asvent holes of the patient interface.

Patient: A person, whether or not they are suffering from a respiratorycondition.

Pressure: Force per unit area. Pressure may be expressed in a range ofunits, including cmH₂O, g-f/cm² and hectopascal. 1 cmH₂O is equal to 1g-f/cm² and is approximately 0.98 hectopascal. In this specification,unless otherwise stated, pressure is given in units of cmH₂O.

The pressure in the patient interface is given the symbol Pm, while thetreatment pressure, which represents a target value to be achieved bythe mask pressure Pm at the current instant of time, is given the symbolPt.

Respiratory Pressure Therapy (RPT): The application of a supply of airto an entrance to the airways at a treatment pressure that is typicallypositive with respect to atmosphere.

Ventilator: A mechanical device that provides pressure support to apatient to perform some or all of the work of breathing.

5.7.1.1 Materials

Silicone or Silicone Elastomer: A synthetic rubber. In thisspecification, a reference to silicone is a reference to liquid siliconerubber (LSR) or a compression moulded silicone rubber (CMSR). One formof commercially available LSR is SILASTIC (included in the range ofproducts sold under this trademark), manufactured by Dow Corning.Another manufacturer of LSR is Wacker. Unless otherwise specified to thecontrary, an exemplary form of LSR has a Shore A (or Type A) indentationhardness in the range of about 35 to about 45 as measured using ASTMD2240.

Polycarbonate: a thermoplastic polymer of Bisphenol-A Carbonate.

5.7.1.2 Mechanical Properties

Resilience: Ability of a material to absorb energy when deformedelastically and to release the energy upon unloading.

Resilient: Will release substantially all of the energy when unloaded.Includes e.g. certain silicones, and thermoplastic elastomers.

Hardness: The ability of a material per se to resist deformation (e.g.described by a Young's Modulus, or an indentation hardness scalemeasured on a standardised sample size).

-   -   ‘Soft’ materials may include silicone or thermo-plastic        elastomer (TPE), and may, e.g. readily deform under finger        pressure.    -   ‘Hard’ materials may include polycarbonate, polypropylene, steel        or aluminium, and may not e.g. readily deform under finger        pressure.

Stiffness (or rigidity) of a structure or component: The ability of thestructure or component to resist deformation in response to an appliedload. The load may be a force or a moment, e.g. compression, tension,bending or torsion. The structure or component may offer differentresistances in different directions.

Floppy structure or component: A structure or component that will changeshape, e.g. bend, when caused to support its own weight, within arelatively short period of time such as 1 second.

Rigidstructure or component: A structure or component that will notsubstantially change shape when subject to the loads typicallyencountered in use. An example of such a use may be setting up andmaintaining a patient interface in sealing relationship with an entranceto a patient's airways, e.g. at a load of approximately 20 to 30 cmH₂Opressure.

As an example, an I-beam may comprise a different bending stiffness(resistance to a bending load) in a first direction in comparison to asecond, orthogonal direction. In another example, a structure orcomponent may be floppy in a first direction and rigid in a seconddirection.

5.7.2 Patient Interface

Anti-asphyxia valve (AAV): The component or sub-assembly of a masksystem that, by opening to atmosphere in a failsafe manner, reduces therisk of excessive CO₂ rebreathing by a patient.

Elbow: An elbow is an example of a structure that directs an axis offlow of air travelling therethrough to change direction through anangle. In one form, the angle may be approximately 90 degrees. Inanother form, the angle may be more, or less than 90 degrees. The elbowmay have an approximately circular cross-section. In another form theelbow may have an oval or a rectangular cross-section. In certain formsan elbow may be rotatable with respect to a mating component, e.g. about360 degrees. In certain forms an elbow may be removable from a matingcomponent, e.g. via a snap connection. In certain forms, an elbow may beassembled to a mating component via a one-time snap during manufacture,but not removable by a patient.

Frame: Frame will be taken to mean a mask structure that bears the loadof tension between two or more points of connection with a headgear. Amask frame may be a non-airtight load bearing structure in the mask.However, some forms of mask frame may also be air-tight.

Headgear: Headgear will be taken to mean a form of positioning andstabilizing structure designed for use on a head. For example theheadgear may comprise a collection of one or more struts, ties andstiffeners configured to locate and retain a patient interface inposition on a patient's face for delivery of respiratory therapy. Someties are formed of a soft, flexible, elastic material such as alaminated composite of foam and fabric.

Membrane: Membrane will be taken to mean a typically thin element thathas, preferably, substantially no resistance to bending, but hasresistance to being stretched.

Plenum chamber: a mask plenum chamber will be taken to mean a portion ofa patient interface having walls at least partially enclosing a volumeof space, the volume having air therein pressurised above atmosphericpressure in use. A shell may form part of the walls of a mask plenumchamber.

Seal: May be a noun form (“a seal”) which refers to a structure, or averb form (“to seal”) which refers to the effect. Two elements may beconstructed and/or arranged to ‘seal’ or to effect ‘sealing’therebetween without requiring a separate ‘seal’ element per se.

Shell: A shell will be taken to mean a curved, relatively thin structurehaving bending, tensile and compressive stiffness. For example, a curvedstructural wall of a mask may be a shell. In some forms, a shell may befaceted. In some forms a shell may be airtight. In some forms a shellmay not be airtight.

Stiffener: A stiffener will be taken to mean a structural componentdesigned to increase the bending resistance of another component in atleast one direction.

Strut: A strut will be taken to be a structural component designed toincrease the compression resistance of another component in at least onedirection.

Swivel (noun): A subassembly of components configured to rotate about acommon axis, preferably independently, preferably under low torque. Inone form, the swivel may be constructed to rotate through an angle of atleast 360 degrees. In another form, the swivel may be constructed torotate through an angle less than 360 degrees. When used in the contextof an air delivery conduit, the sub-assembly of components preferablycomprises a matched pair of cylindrical conduits. There may be little orno leak flow of air from the swivel in use.

Tie (noun): A structure designed to resist tension.

Vent: (noun): A structure that allows a flow of air from an interior ofthe mask, or conduit, to ambient air for clinically effective washout ofexhaled gases. For example, a clinically effective washout may involve aflow rate of about 10 litres per minute to about 100 litres per minute,depending on the mask design and treatment pressure.

5.7.3 Shape of Structures

Products in accordance with the present technology may comprise one ormore three-dimensional mechanical structures, for example a mask cushionor an impeller. The three-dimensional structures may be bounded bytwo-dimensional surfaces. These surfaces may be distinguished using alabel to describe an associated surface orientation, location, function,or some other characteristic. For example a structure may comprise oneor more of an anterior surface, a posterior surface, an interior surfaceand an exterior surface. In another example, a seal-forming structuremay comprise a face-contacting (e.g. outer) surface, and a separatenon-face-contacting (e.g. underside or inner) surface. In anotherexample, a structure may comprise a first surface and a second surface.

To facilitate describing the shape of the three-dimensional structuresand the surfaces, we first consider a cross-section through a surface ofthe structure at a point, p. See FIG. 3B to FIG. 3F, which illustrateexamples of cross-sections at point p on a surface, and the resultingplane curves. FIGS. 3B to 3F also illustrate an outward normal vector atp. The outward normal vector at p points away from the surface. In someexamples we describe the surface from the point of view of an imaginarysmall person standing upright on the surface.

5.7.3.1 Curvature in One Dimension

The curvature of a plane curve at p may be described as having a sign(e.g. positive, negative) and a magnitude (e.g. 1/radius of a circlethat just touches the curve at p).

Positive curvature: If the curve at p turns towards the outward normal,the curvature at that point will be taken to be positive (if theimaginary small person leaves the point p they must walk uphill). SeeFIG. 3B (relatively large positive curvature compared to FIG. 3C) andFIG. 3C (relatively small positive curvature compared to FIG. 3B). Suchcurves are often referred to as concave.

Zero curvature: If the curve at p is a straight line, the curvature willbe taken to be zero (if the imaginary small person leaves the point p,they can walk on a level, neither up nor down). See FIG. 3D.

Negative curvature: If the curve at p turns away from the outwardnormal, the curvature in that direction at that point will be taken tobe negative (if the imaginary small person leaves the point p they mustwalk downhill). See FIG. 3E (relatively small negative curvaturecompared to FIG. 3F) and FIG. 3F (relatively large negative curvaturecompared to FIG. 3E). Such curves are often referred to as convex.

5.7.3.2 Curvature of Two Dimensional Surfaces

A description of the shape at a given point on a two-dimensional surfacein accordance with the present technology may include multiple normalcross-sections. The multiple cross-sections may cut the surface in aplane that includes the outward normal (a “normal plane”), and eachcross-section may be taken in a different direction. Each cross-sectionresults in a plane curve with a corresponding curvature. The differentcurvatures at that point may have the same sign, or a different sign.Each of the curvatures at that point has a magnitude, e.g. relativelysmall. The plane curves in FIGS. 3B to 3F could be examples of suchmultiple cross-sections at a particular point.

Principal curvatures and directions: The directions of the normal planeswhere the curvature of the curve takes its maximum and minimum valuesare called the principal directions. In the examples of FIG. 3B to FIG.3F, the maximum curvature occurs in FIG. 3B, and the minimum occurs inFIG. 3F, hence FIG. 3B and FIG. 3F are cross sections in the principaldirections. The principal curvatures at p are the curvatures in theprincipal directions.

Region of a surface: A connected set of points on a surface. The set ofpoints in a region may have similar characteristics, e.g. curvatures orsigns.

Saddle region: A region where at each point, the principal curvatureshave opposite signs, that is, one is positive, and the other is negative(depending on the direction to which the imaginary person turns, theymay walk uphill or downhill).

Dome region: A region where at each point the principal curvatures havethe same sign, e.g. both positive (a “concave dome”) or both negative (a“convex dome”).

Cylindrical region: A region where one principal curvature is zero (or,for example, zero within manufacturing tolerances) and the otherprincipal curvature is non-zero.

Planar region: A region of a surface where both of the principalcurvatures are zero (or, for example, zero within manufacturingtolerances).

Edge of a surface: A boundary or limit of a surface or region.

Path: In certain forms of the present technology, ‘path’ will be takento mean a path in the mathematical—topological sense, e.g. a continuousspace curve from f(0) to f(1) on a surface. In certain forms of thepresent technology, a ‘path’ may be described as a route or course,including e.g. a set of points on a surface. (The path for the imaginaryperson is where they walk on the surface, and is analogous to a gardenpath).

Path length: In certain forms of the present technology, ‘path length’will be taken to mean the distance along the surface from f(0) to f(1),that is, the distance along the path on the surface. There may be morethan one path between two points on a surface and such paths may havedifferent path lengths. (The path length for the imaginary person wouldbe the distance they have to walk on the surface along the path).

Straight-line distance: The straight-line distance is the distancebetween two points on a surface, but without regard to the surface. Onplanar regions, there would be a path on the surface having the samepath length as the straight-line distance between two points on thesurface. On non-planar surfaces, there may be no paths having the samepath length as the straight-line distance between two points. (For theimaginary person, the straight-line distance would correspond to thedistance ‘as the crow flies’.)

5.7.3.3 Space Curves

Space curves: Unlike a plane curve, a space curve does not necessarilylie in any particular plane. A space curve may be closed, that is,having no endpoints. A space curve may be considered to be aone-dimensional piece of three-dimensional space. An imaginary personwalking on a strand of the DNA helix walks along a space curve. Atypical human left ear comprises a helix, which is a left-hand helix,see FIG. 3Q. A typical human right ear comprises a helix, which is aright-hand helix, see FIG. 3R. FIG. 3S shows a right-hand helix. Theedge of a structure, e.g. the edge of a membrane or impeller, may followa space curve. In general, a space curve may be described by a curvatureand a torsion at each point on the space curve. Torsion is a measure ofhow the curve turns out of a plane. Torsion has a sign and a magnitude.The torsion at a point on a space curve may be characterised withreference to the tangent, normal and binormal vectors at that point.

Tangent unit vector (or unit tangent vector): For each point on a curve,a vector at the point specifies a direction from that point, as well asa magnitude. A tangent unit vector is a unit vector pointing in the samedirection as the curve at that point. If an imaginary person were flyingalong the curve and fell off her vehicle at a particular point, thedirection of the tangent vector is the direction she would betravelling.

Unit normal vector: As the imaginary person moves along the curve, thistangent vector itself changes. The unit vector pointing in the samedirection that the tangent vector is changing is called the unitprincipal normal vector. It is perpendicular to the tangent vector.

Binormal unit vector: The binormal unit vector is perpendicular to boththe tangent vector and the principal normal vector. Its direction may bedetermined by a right-hand rule (see e.g. FIG. 3P), or alternatively bya left-hand rule (FIG. 3O).

Osculating plane: The plane containing the unit tangent vector and theunit principal normal vector. See FIGS. 3O and 3P.

Torsion of a space curve: The torsion at a point of a space curve is themagnitude of the rate of change of the binormal unit vector at thatpoint. It measures how much the curve deviates from the osculatingplane. A space curve which lies in a plane has zero torsion. A spacecurve which deviates a relatively small amount from the osculating planewill have a relatively small magnitude of torsion (e.g. a gently slopinghelical path). A space curve which deviates a relatively large amountfrom the osculating plane will have a relatively large magnitude oftorsion (e.g. a steeply sloping helical path). With reference to FIG.3S, since T2>T1, the magnitude of the torsion near the top coils of thehelix of FIG. 3S is greater than the magnitude of the torsion of thebottom coils of the helix of FIG. 3S

With reference to the right-hand rule of FIG. 3P, a space curve turningtowards the direction of the right-hand binormal may be considered ashaving a right-hand positive torsion (e.g. a right-hand helix as shownin FIG. 3S). A space curve turning away from the direction of theright-hand binormal may be considered as having a right-hand negativetorsion (e.g. a left-hand helix).

Equivalently, and with reference to a left-hand rule (see FIG. 3O), aspace curve turning towards the direction of the left-hand binormal maybe considered as having a left-hand positive torsion (e.g. a left-handhelix). Hence left-hand positive is equivalent to right-hand negative.See FIG. 3T.

5.7.3.4 Holes

A surface may have a one-dimensional hole, e.g. a hole bounded by aplane curve or by a space curve. Thin structures (e.g. a membrane) witha hole, may be described as having a one-dimensional hole. See forexample the one dimensional hole in the surface of structure shown inFIG. 3I, bounded by a plane curve.

A structure may have a two-dimensional hole, e.g. a hole bounded by asurface. For example, an inflatable tyre has a two dimensional holebounded by the interior surface of the tyre. In another example, abladder with a cavity for air or gel could have a two-dimensional hole.See for example the cushion of FIG. 3L and the example cross-sectionstherethrough in FIG. 3M and FIG. 3N, with the interior surface boundinga two dimensional hole indicated. In a yet another example, a conduitmay comprise a one-dimension hole (e.g. at its entrance or at its exit),and a two-dimension hole bounded by the inside surface of the conduit.See also the two dimensional hole through the structure shown in FIG.3K, bounded by a surface as shown.

5.8 Other Remarks

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in Patent Office patent files orrecords, but otherwise reserves all copyright rights whatsoever.

Unless the context clearly dictates otherwise and where a range ofvalues is provided, it is understood that each intervening value, to thetenth of the unit of the lower limit, between the upper and lower limitof that range, and any other stated or intervening value in that statedrange is encompassed within the technology. The upper and lower limitsof these intervening ranges, which may be independently included in theintervening ranges, are also encompassed within the technology, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as beingimplemented as part of the technology, it is understood that such valuesmay be approximated, unless otherwise stated, and such values may beutilized to any suitable significant digit to the extent that apractical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

When a particular material is identified as being used to construct acomponent, obvious alternative materials with similar properties may beused as a substitute. Furthermore, unless specified to the contrary, anyand all components herein described are understood to be capable ofbeing manufactured and, as such, may be manufactured together orseparately.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

All publications mentioned herein are incorporated herein by referencein their entirety to disclose and describe the methods and/or materialswhich are the subject of those publications. The publications discussedherein are provided solely for their disclosure prior to the filing dateof the present application. Nothing herein is to be construed as anadmission that the present technology is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dates,which may need to be independently confirmed.

The terms “comprises” and “comprising” should be interpreted asreferring to elements, components, or steps in a non-exclusive manner,indicating that the referenced elements, components, or steps may bepresent, or utilized, or combined with other elements, components, orsteps that are not expressly referenced.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein has been described with reference toparticular examples, it is to be understood that these examples aremerely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative examples and that other arrangements may be devisedwithout departing from the spirit and scope of the technology.

5.9 REFERENCE SIGNS LIST Feature Item Number patient 1000 bed partner1100 patient interface 3000 seal-forming structure 3100 plenum chamber3200 stabilizing structure 3300 vent 3400 connection port 3600 foreheadsupport 3700 RPT device 4000 air circuit 4170 humidifier 5000 waterreservoir 5110 reservoir base 5112 reservoir lid 5114 compliant portion5116 inlet 5118 heater plate 5120 outlet 5122 water reservoir dock 5130orifice 5138 base upper body 5146 base bottom plate 5148 side wall5149.1 bottom wall 5149.2 hole 5149.3 thin film 5152 first side 5152.1second side 5152.2 hinge 5158 cavity 5160 dock air outlet 5168 dock airinlet 5170 humidifier outlet 5172 rib 5175 humidifier transducer 5210air pressure sensor 5212 air flow rate transducer 5214 temperaturesensor 5216 humidity sensor 5218 inner lip 5224 outer lip 5226 heatingelement 5240 humidifier controller 5250 central humidifier controller5251 heating element controller 5252 air circuit controller 5254

1.-20. (canceled)
 21. A water reservoir for an apparatus for generatingand humidifying a flow of breathable gas, the water reservoir beingconfigured for being removably received by a water reservoir dock of theapparatus, the water reservoir dock comprising a heater plate, the waterreservoir comprising: a reservoir base including a bottom wall and sidewalls forming a cavity structured to hold a volume of liquid; and a thinfilm provided to the reservoir base, at least a portion of the thin filmadapted to thermally engage with the heater plate when the waterreservoir is removably received by the water reservoir dock to allowthermal transfer of heat from the heater plate to the volume of liquidin use, wherein the thin film includes: a/ a first side including atleast a portion adapted to form a bottom interior surface of the waterreservoir exposed to the volume of liquid, and b/ a second side,opposite to the first side, wherein the second side of the thin filmincludes at least a portion adapted to form a bottom, exposed exteriorsurface of the water reservoir exposable to the heater plate to allowthermal engagement with the heater plate when the water reservoir isremovably received by the water reservoir dock, wherein the thin filmcomprises a non-metallic material, wherein the thin film includes a wallthickness less than about 1 mm, wherein at least a portion of the bottomwall extends transverse to the side walls and said portion of the bottomwall forms an interior surface of the water reservoir exposed to thevolume of liquid, and wherein said portion of the bottom wall of thereservoir base includes a hole, and the thin film is secured so that thethin film sealingly covers the hole and perimeter edges of the thin filmextend beyond edges of the hole such that the thin film overlaps with atleast a portion of the interior surface of the bottom wall.
 22. Thewater reservoir according to claim 21, wherein the wall thickness isless than about 0.5 mm.
 23. The water reservoir according to claim 21,wherein the thin film comprises silicone, polycarbonate, or otherthermoplastic or elastomeric materials.
 24. The water reservoiraccording to claim 21, wherein the thin film is provided as a separateand distinct structure from the reservoir base.
 25. The water reservoiraccording to claim 21, wherein the thin film comprises a pre-formedstructure that is secured or otherwise provided to the reservoir base.26. The water reservoir according to claim 21, wherein the thin film isgenerally planar.
 27. The water reservoir according to claim 21, whereinthe second side of the thin film provides a contact surface structuredand arranged to directly engage with the heater plate when the waterreservoir is removably received by the water reservoir dock.
 28. Thewater reservoir according to claim 21, wherein the non-metallic materialof the thin film is similar to a material of the reservoir base.
 29. Thewater reservoir according to claim 21, wherein the wall thickness of thethin film is less than a wall thickness of the bottom and side walls ofthe reservoir base.
 30. The water reservoir according to claim 21,wherein at least a portion of the side walls of the reservoir base formsan interior surface of the water reservoir exposed to the volume ofliquid, and wherein the perimeter edges of the thin film extend to oneor more of the side walls of the reservoir base such that the thin filmoverlaps with at least a portion of the interior surface of one or moreof the side walls of the reservoir base.
 31. The water reservoiraccording to claim 21, further comprising a reservoir lid movablyconnected to the reservoir base to allow the water reservoir to beconvertible between an open configuration and a closed configuration.32. The water reservoir according to claim 21, wherein the thin filmincludes one or more additives to promote thermal conductivity.
 33. Thewater reservoir according to claim 32, wherein the thin film comprises aceramic powder additive and/or a metallic powder additive.
 34. The waterreservoir according to claim 21, wherein the thin film comprisesmultiple layers.
 35. The water reservoir according to claim 34, whereinthe thin film comprises a metallic layer and at least one plastic layer.36. The water reservoir according to claim 35, wherein the at least oneplastic layer comprises a plastic layer on both sides of the metalliclayer.
 37. The water reservoir according to claim 21, wherein the thinfilm comprises a coating of a thermally conductive material applied toone side of the thin film.
 38. An apparatus for humidifying a flow ofbreathable gas, comprising: a water reservoir dock; and the waterreservoir according to claim 21 provided to the water reservoir dock.39. The apparatus according to claim 38, wherein the water reservoirdock forms a cavity to at least partially receive the water reservoir.40. The apparatus according to claim 38, wherein the water reservoirdock includes the heater plate adapted to thermally engage the thin filmprovided to the water reservoir.